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Basilea and J&J initiate phase III antibiotic trials

Basilea Pharmaceutica AG and Johnson & Johnson Pharmaceutical R&D have moved their first-in-class antibiotic, BAL5788, into phase III clinical trials in hospital-acquired pneumonia.

The two companies have initiated enrolment in the international randomized controlled phase III study, named CHOPIN, to evaluate BAL5788 (ceftobiprole) in hospital-acquired pneumonia including ventilator-associated pneumonia.

“We are pleased to announce the advancement of BAL5788 into phase III clinical trials for the second indication of nosocomial pneumonia in addition to the earlier commenced phase III clinical trials in complicated skin and skin structure infections,” said Dr Rienk Pypstra, chief development officer of Basilea.

“Based on its broad Gram-positive and Gram-negative antibiotic profile, including activity on MRSA, its low probability of inducing resistance and its expected cephalosporin-like safety profile, BAL5788 has the potential to become a drug of choice in hospital-acquired pneumonia,” he continued.

Hospital-acquired pneumonia is one of the most common infections in intensive care units and accounts for some 15% of all hospital infections. The mortality rate exceeds 30% and is highest among mechanically ventilated patients and patients infected with methicillin-resistant Staphylococcus aureus (MRSA).